Air Optix® Night and Day® Aqua Continuous Wear
Study Details
Study Description
Brief Summary
The purpose of this retrospective, Post-Market Clinical Follow-Up (PMCF) study is to assess the long term performance and safety of Air Optix® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as 30 days of continuous wear for vision correction.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
This is a non-interventional/observational study designed as a retrospective chart review. Study sites will identify charts within their existing databases in a fair and consistent manner. Subjects/charts meeting the eligibility criteria will be enrolled in the study.
The study is designed with one period. The duration of the period includes the Baseline Visit and the Year 3 Visit as follows:
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The Baseline Visit is defined as the first office visit where an eye care professional provided an in-person office biomicroscopy exam to the subject, before or during which a contact lens prescription for AONDA or PureVision 2 (PV2) was released.
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The Year 3 Visit is defined as a visit which occurred 3 years (-2/+8 months) since Baseline during which period the subject was wearing AONDA contact lenses or PV2 contact lenses and a contact lens examination was performed.
The data collection period is defined as any approximately 3-year timeframe since and including 2009.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| AONDA contact lenses Lotrafilcon A contact lenses worn in a 30-day, continuous wear modality (lenses worn continuously including overnight) over a period of approximately 3 years |
Device: Lotrafilcon A contact lenses
CE-marked silicone hydrogel contact lenses
Other Names:
|
| PV2 contact lenses Balafilcon A contact lenses worn in a 30-day, continuous wear modality (lenses worn continuously including overnight) over a period of approximately 3 years |
Device: Balafilcon A contact lenses
CE-marked silicone hydrogel contact lenses
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Distance visual acuity [Year 3]
The subject's chart will be reviewed for distance visual acuity.
- Incidence of corneal infiltrative events [Up to Year 3]
The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the Baseline Visit exam.
- Incidence of microbial keratitis [Up to Year 3]
The subject's chart will be reviewed for incidences of microbial keratitis occurring after the Baseline Visit exam.
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Manifest refraction cylinder less than or equal to 0.75 diopter in each eye at baseline
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Best corrected visual acuity of 20/25 or better in each eye at baseline
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At the time of Year 3 Visit, subject was prescribed and wearing AONDA or PV2 contact lenses in both eyes in a 30-day continuous wear modality for at least approximately 3 years
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Baseline Visit and Year 3 Visit charts available
Key Exclusion Criteria:
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Any recurrent history or active anterior segment infection, inflammation, abnormality, or disease contraindicating regular contact lens wear present at baseline
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The use of systemic or ocular medications contraindicating regular contact lens wear at baseline
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History of refractive surgery or irregular cornea
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Slit lamp findings, including signs of pathological dry eye, that would contraindicate regular contact lens wear at baseline
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Clinical Trial Lead, CRD Vision Care, Alcon Research, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLD265-N003